FDA.reportPublic FDA data

IMMCO DIAGNOSTICS

Primary DI
00845714002786
Brand
IMMCO DIAGNOSTICS
Company
IMMCO DIAGNOSTICS, INC.
Model
2316
Catalog number
2316
Device description
Stop Solution
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DHRSystem, Test, Rheumatoid Factor
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
LLLExtractable Antinuclear Antibody, Antigen And Control
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
MIDSystem, Test, Anticardiolipin Immunological
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
MSTAntibodies, Gliadin
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHRSystem, Test, Rheumatoid FactorImmunology2
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, ControlsImmunology2
LLLExtractable Antinuclear Antibody, Antigen And ControlImmunology2
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, ControlImmunology2
MIDSystem, Test, Anticardiolipin ImmunologicalImmunology2
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)Immunology2
MSTAntibodies, GliadinImmunology2
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)Immunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845714002786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714002786008457140027868457140027860845714002786

GMDN Terms#

Term, Definition table
TermDefinition
Sulphuric acid stop solution reagent IVDA dilute sulphuric acid solution intended to be used to stop enzymatic activity or further development of reactions during the final processing steps of an enzyme immunoassay method, when testing clinical laboratory specimens.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-537-8378INFO@IMMCO.COM

Regulatory Flags#

DUNS number
079935300
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845714000003IMMCO DIAGNOSTICS110211022016-09-21
00845714000010IMMCO DIAGNOSTICS110311032016-09-21
00845714000089IMMCO DIAGNOSTICS113611362016-09-21
00845714000096IMMCO DIAGNOSTICS1136-961136-962016-09-21
00845714000218IMMCO DIAGNOSTICS117511752016-09-21
00845714000249IMMCO DIAGNOSTICS 1102-601102-602016-09-21
00845714000287IMMCO DIAGNOSTICS110711072016-09-21
00845714000393IMMCO DIAGNOSTICS112511252016-09-21
00845714000430IMMCO DIAGNOSTICS113411342016-09-21
00845714000461IMMCO DIAGNOSTICS1136-2501136-2502016-09-21
00845714000829IMMCO DIAGNOSTICS1102-1201102-1202016-09-21
00845714000836IMMCO DIAGNOSTICS1102-120X1102-120X2016-09-21
00845714000843IMMCO DIAGNOSTICS1102-60X1102-60X2016-09-21
00845714000867IMMCO DIAGNOSTICS 1102X1102X2016-09-21
00845714000874IMMCO DIAGNOSTICS1103-2401103-2402016-09-21
00845714000881IMMCO DIAGNOSTICS 1103-240X1103-240X2016-09-21
00845714000898IMMCO DIAGNOSTICS1103-4801103-4802016-09-21
00845714000904IMMCO DIAGNOSTICS1103-480X1103-480X2016-09-21
00845714000928IMMCO DIAGNOSTICS1103X1103X2016-09-21
00845714001017IMMCO DIAGNOSTICS1107-11107-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08426951011193HemosIL CL Anti-Cardiolipin IgMINSTRUMENTATION LABORATORY COMPANYMID2026-04-08
00845533002011Endomysium (Primate esophagus)ZEUS SCIENTIFIC, INC.MVM2025-10-17
08059304340239dIFine ANCA ClassifierVISIA LAB SRLMOB2025-06-27
08430793040471Aptiva® Celiac Disease IgG ReagentINOVA DIAGNOSTICS, INC.MST2022-05-27
08430793040471Aptiva® Celiac Disease IgG ReagentINOVA DIAGNOSTICS, INC.MVM2022-05-27
08430793040532Aptiva® Celiac Disease IgA ReagentINOVA DIAGNOSTICS, INC.MST2022-05-27
08430793040532Aptiva® Celiac Disease IgA ReagentINOVA DIAGNOSTICS, INC.MVM2022-05-27
00816426021457K-ASSAY® RF Reagent (Ver.2)KAMIYA BIOMEDICAL COMPANY, LLCDHR2020-11-03
00847865013000BioPlex 2200BIO-RAD LABORATORIES, INC.MST2020-01-30
08426950793182QUANTA Flash® HMGCR ReagentsINOVA DIAGNOSTICS, INC.LLL2018-10-31
04049016108535IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108542IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108559IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108566IFA: Granulocyte Mosaic 13 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108634IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108641IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108658IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108665IFA: Granulocyte Mosaic 2 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108733EUROPLUS Granulocyte Mosaic 22 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108740EUROPLUS Granulocyte Mosaic 22 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108757EUROPLUS Granulocyte Mosaic 22 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108764EUROPLUS Granulocyte Mosaic 22 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108832EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108849EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108856EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108863EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108931EUROPLUS Granulocyte Mosaic 32 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108948EUROPLUS Granulocyte Mosaic 32 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108955EUROPLUS Granulocyte Mosaic 32 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04
04049016108962EUROPLUS Granulocyte Mosaic 32 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMOB2018-06-04